WARNINGS
Fatalities have occurred, although rarely, due to severe
reactions to sulfonamides including Stevens- Johnson syndrome,
toxic epidermal necrolysis, fulminant hepatic necrosis,
agranulocytosis, aplastic anemia, and other blood dyscrasias.
Sensitizations may recur when a sulfonamide is readministered
irrespective of the route of administration. If signs of
hypersensitivity or other serious reactions occur, discontinue
use of this drug.
Caution is advised for patients receiving concomitant
high- dose aspirin and acetazolamide, as anorexia, tachypnea,
lethargy, coma and death have been reported.
PRECAUTIONS
Increasing the dose does not increase the diuresis and
may increase the incidence of drowsiness and or paresthesia.
Increasing the dose often results in a decrease in diuresis.
Under certain circumstances, however, very large doses
have been given in conjunction with other diuretics in
order to secure diuresis in complete refractory failure.
lnformation for Patients
Adverse reactions common to all sulfonamide derivatives
may occur: anaphylaxis, fever, rash (including erythema
multiforme, Stevens- Johnson syndrome, toxic epidermal
necrolysis), crystalluria, renal calculus, bone marrow
depression, thrombocytopenic purpura, hemolytic anemia,
leukopenia, pancytopenia and agranulocytosis. Precaution
is advised for early detection of such reactions and the
drug should be discontinued and appropriate therapy instituted.
In patients with pulmonary obstruction or emphysema where
alveolar ventilation may be impaired, acetazolamide which
may precipitate or aggravate acidosis, should be used
with caution.
Gradual ascent is desirable to try to avoid acute mountain
sickness. If rapid ascent is undertaken and acetazolamide
is used, it should be noted that such use does not obviate
the need for prompt descent if severe forms of high altitude
sickness occur, i. e., high altitude pulmonary edema (HAPE)
or high- altitude cerebral edema.
Caution is advised for patients receiving concomitant
high- dose aspirin and acetazolamide, as anorexia, tachypnea,
lethargy, coma and death have been reported (see WARNlNGS).
To monitor for hematologic reactions common to all sulfonamides,
it is recommended that a baseline CBC and platelet count
be obtained on patients prior to initiating acetazolamide
therapy and at regular intervals during therapy. If significant
changes occur, early discontinuance and institution of
appropriate therapy are important. Periodic monitoring
of serum electrolytes is recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long- term studies in animals to evaluate the carcinogenic
potential of acetazolamide have not been conducted. In
a bacterial mutagenicity assay, acetazolamide was not
mutagenic when evaluated with and without metabolic activation.
The drug had no effect on fertility when administered
in the diet to male and female rats at a daily intake
of up to 4 times the recommended human dose of 1000 mg
in a 50 kg individual.
Pregnancy Category C
Acetazolamide, administered orally, has been shown to
be teratogenic (defects of the limbs) in mice, rats, hamsters
and rabbits. There are no adequate and well-controlled
studies in pregnant women. Acetazolamide should be used
in pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Nursing Mothers
Because of the potential for serious adverse reaction
in nursing infants from acetazolamide, a decision should
be made whether to discontinue nursing or to discontinue
the drug taking into account the importance of the drug
to the mother.
Pediatric Use
The safety and effectiveness of acetazolamide in children
have not been established.
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